MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	DXW150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a3b, a4 and a5: unknown/ asked but not available.Section b3: date of event: unknown, not provided, section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1:surgeon's name email address and phone number: unknown/ asked but not available.Device evaluation: at the time of the investigation, device was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from patient's eye and cut in two places and one in medial and one lateral and that was in periphery.There must have been burrs on both the haptics.The lens want implanted in bag and ¿nicked bag¿ upon rotation.No other information is available.
Additional Manufacturer Narrative
Section b5: upon further review of the file it was noticed that information was invertedly missed within the initial mdr that the lens is still implanted the lens expanded and cut capsule in two places one medial and one lateral and that was in periphery, there must have been burrs on both haptics.No further information provided.Section d6b: if explanted, give date: not applicable as lens remains implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19841314
• Report Number: 3012236936-2024-000203
• Device Sequence Number: 20495128
• Product Code: HQL
• UDI-Device Identifier: 05050474763159
• UDI-Public: (01)05050474763159(17)250802
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown